Medlab Clinical Ltd Equity Research & Stock Reports

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23 Jan 23

Medlab Clinical - NanaBis development centre stage in 2023

As Medlab Clinical moves into 2023, the expected commencement of a Phase III trial for NanaBis (the company’s cannabinoid based analgesic therapy) in cancer-induced bone pain will be the focus for investors. Management made considerable progress towards Phase III in 2022, by switching to a purely synthetic cannabinoid formulation and gathering encouraging real-world data on NanaBis use. We believe these actions should maximise the potential for NanaBis in both a regulatory and a commercial setti

Companies: Medlab Clinical Ltd

Edison

17 Jan 23

Medlab Clinical - Encouraging real-world data to support NanaBis

Medlab Clinical has announced positive interim data from its real-world evidence study for NanaBis (Medcare observational study). The 12-month study comprised 1,172 patients (with both cancer and non-cancer related pain) and exhibited a good safety, tolerability and sustainability profile for NanaBis use. The enrolled patients reported a 55% improvement in pain relief, along with reduced opioid use in 75% of the patients. Importantly, 92% of the patients with cancer bone metastasis reported redu

Companies: Medlab Clinical Ltd

Edison

04 Jan 23

Medlab Clinical - Moving closer to the Nasdaq IPO

Medlab Clinical moves a step closer to realising its plans for a secondary listing on the Nasdaq following filing of the IPO registration statement with the US Securities and Exchange Commission. As part of the offering, the company plans to issue c 1.8m share units (ordinary shares plus an equivalent number of warrants) at US$4.45/share and c 1.8m pre-funded warrants at US$4.4999/unit (nominal exercise price of US$0.0001/unit) to raise c US$8m in gross IPO proceeds (c US$7m net). Following this

Companies: Medlab Clinical Ltd

Edison

12 Dec 22

Medlab Clinical - Progressing on multiple fronts

Medlab Clinical has announced that it has cleared the Securities Exchange Commission’s (SEC’s) comments on its Nasdaq listing and is now preparing to finalise its application with its US broker, Alliance Global Partners. After this announcement, we expect Medlab will remain on track to meet its listing target timeline of Q1 CY23, which coincides with the anticipated investigational new drug (IND) submission for NanaBis in the US (to start Phase III trials). Due to the high activity and liquidity

Companies: Medlab Clinical Ltd

Edison

29 Nov 22

Medlab Clinical - UK compassionate use for alternative to opioids

Medlab Clinical has announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its lead product NanaBis (NanaDol in the UK) to be used under its Named Patient Program and other compassionate areas. NanaDol, a botanical version of NanaBis as a 50:50 formulation of CBD and THC, has previously shown encouraging Phase I/II data for the treatment of cancer-induced bone pain and a potentially valuable alternative to opioids. We see the MHRA appro

Companies: Medlab Clinical Ltd

Edison

31 Oct 22

Medlab Clinical - Cash position supported by A$3.6m R&D grant

Medlab Clinical has released its unaudited cash flow report for Q123 and provided an update for the period. The company’s cash position was bolstered by the receipt of A$0.3m from sales of NanaBis and NanoCBD (under the Doctors Special Access Scheme) as well as a A$3.6m government R&D grant. In the absence of the grant, the company’s net cash outflow from operating activities for the quarter was A$3.5m. At the current burn rate and with a net cash position of A$5.3m (A$5.2m at end-FY22), we esti

Companies: Medlab Clinical Ltd

Edison

20 Sep 22

Medlab Clinical - Observational trials to support development

Medlab Clinical has announced it has received ethics approval to conduct two new observational clinical trials in Australia for its lead developmental programmes, NanaBis and NanoCBD. The studies aim to investigate the long-term efficacy, tolerability and safety profiles of the products in the target populations. In our view these studies are an important milestone in the clinical progression of NanaBis and NanoCBD as, assuming positive readouts, the results will help generate data packages to s

Companies: Medlab Clinical Ltd

Edison

02 Sep 22

Medlab Clinical - FY23 a year of clinical development

As part of its transformation into a pureplay biotech, Medlab is preparing an IND submission for NanaBis and plans to begin clinical trials with both NanaBis and NanoCBD in the next 12 months. In FY22, Medlab’s total revenue from continued operations increased 35.3% y-o-y, however, total group revenue was up 5.3%% y-o-y, due to the licensing of the nutraceutical business in October 2021. The net cash outflow from operating activities in FY22 was A$9.3m, in line with our estimates. We see a poten

Companies: Medlab Clinical Ltd

Edison

02 Aug 22

Medlab Clinical - FY22 cash flows within our expectations

Medlab Clinical has released its cash flow report for Q422 and the full FY22 period. Net cash outflow from operating activities in FY22 was A$9.0m, roughly in line with our estimate of A$9.3m. The company reported cash operating revenues for the year of A$6.2m, however it expects to record a A$3.5m research and development grant post the period end (in September/October 2022). Total cash outflow for FY22 was A$8.2m, which was lower than our estimate of A$9.3m as the company received A$750k and w

Companies: Medlab Clinical Ltd

Edison

14 Jul 22

Medlab Clinical - NanaBis – now with synthetic CBD and THC

Following the company’s transformation to a pureplay biotech, Medlab Clinical has focused on the development of key asset NanaBis, a 50:50 micellar formulation of CBD and THC, in the treatment of cancer-induced bone pain. Based on recommendations from the FDA, Medlab has switched to using synthetic active pharmaceutical ingredients (APIs) in NanaBis and is imminently expected to approach the regulators for approval of a Phase III trial. We expect a recently compiled drug master file (DMF) for Na

Companies: Medlab Clinical Ltd

Edison

09 Feb 22

Medlab Clinical: Edison Open House Healthcare 2022

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27 Jan 22

Medlab Clinical - Transforming into a pure-play biotech

In its former shape, Medlab used the cash flows from selling innovative nutraceuticals to fund pharmaceutical research. With lead product NanaBis (NanoCelle encapsulated 50:50 THC:CBD for pain) preparing to enter a Phase III trial in pain, management has decided to fully focus on therapeutics development and divested its nutraceuticals portfolio in November 2021. As a pure-play biotech, Medlab is also focused on optimising its R&D portfolio, which has many initiatives. Historically, Medlab has e

Companies: Medlab Clinical Ltd

Edison

28 Jul 21

Medlab Clinical – executive interview

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12 Jul 21

Medlab Clinical - Novel drug delivery and cannabinoids against pain

Medlab’s proprietary platform, NanoCelle, is a patented nanomicellar formulation that can improve the delivery of drugs. Medlab’s lead product is NanaBis, a combination of THC and CBD (1:1) cannabinoids encapsulated in NanoCelle particles, which enable a convenient buccal spray formulation. A recent breakthrough was Medlab’s announcement that it had successfully produced a synthetic version of NanaBis, which will allow it to move away from a botanical extract. Once the product reformulation is c

Companies: Medlab Clinical Ltd

Edison

24 Jun 21

Medlab Clinical talks upcoming Phase III NanaBis trial and NanoCelle partnering opportunities